Label: TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octinoxate, octisalate and zinc oxide lotion

  • NDC Code(s): 0023-5501-01, 0023-5501-03, 0023-5501-25
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 19, 2013

If you are a consumer or patient please visit this version.

  • Active ingredients

    Homosalate 6.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Zinc Oxide 10.0%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin 

    When using this product keep out of eyes. Rinse with water to remove. 

    Stop use and ask a doctor if rash occurs 

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. 

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply after 80 minutes of swimming or sweating, at least every 2 hours, or after towel drying to avoid lowering protection
    • Sun Protection Measures UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a m -2 p.m., and wearing protective clothing
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Niacinamide, Silica. Glyceryl Stearate. PEG-100 StearatB. Ceteaiyl Alcohol. Squalane, Polygonum Aviculare Extract Physalis Angulata Extract, Dunaliella Salina Extract. Ubiquinone, Glycerin. Camellia Sinensis Leaf Extract Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone. Batyl Alcohol. C12-15 Alkyl Benzoate, Butylene Glycol. Ceteareth-20. Polyhydroxystearic Acid, Isostearic Acid, Acrylates Copolymer, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA. Caprylyl Glycol, Sorbic Acid, Phenoxyethanol

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • store at room temperature 15°- 30°C (59°- 86°F)
  • Questions or comments

    www.skinmedica.com 

  • Principal Display Panel - Carton Label

    TOTAL DEFENSE
    +
    REPAIR
    Broad Spectrum SPF 50+ Sunscreen
    Water Resistant (80 Minutes)
    + INFRARED PROTECTION
    Net Wt. 6 x 1.0 Oz Travel

    TOTAL DEFENSE 
+ 
REPAIR 
Broad Spectrum SPF 50+ Sunscreen
Water Resistant (80 Minutes)
+ INFRARED PROTECTION
Net Wt. 6 x 1.0 Oz Travel

  • INGREDIENTS AND APPEARANCE
    TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 SUNSCREEN 
    homosalate, octinoxate, octisalate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SQUALENE (UNII: 7QWM220FJH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BATILOL (UNII: 39YR661C4U)  
    2'-HYDROXYACETOPHENONE (UNII: 3E533Z76W0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5501-031 in 1 CARTON06/15/2015
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5501-011 in 1 CARTON06/15/2015
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0023-5501-256 in 1 CARTON06/15/2015
    37.08 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/15/2015
    Labeler - Allergan, Inc. (144796497)